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PREVALENCE OF HELICOBACTER PYLORI IN GASTRIC FLUID IN THESURGICAL PATIENT
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PREVALENCE OF HELICOBACTER PYLORI IN GASTRIC FLUID IN THESURGICAL PATIENT
Terence J. McManus
APPROVED:
aqpc onaghan, CLS, SI1B, PhD Chair Date
Andre T. Dubois, PhD Member Date
Patri* C. McMullen,, CRNP, JD Member Dare
Eugene Le6ine, PhD Member Date ,
APPROVED:
F.G. Abdellah,Ed.D.. Sc.D., RN, FAAN Date
(i)
CURRICULUM VITAE
NAME- McManus, Terence J Captain, USAF, NC DOB: 5 Dec 63
HOME ADDRESS: 4007-1 Beech LaneAndrews AFB, MD 20762-5"302
PLACE OF BIRTH: Jackson Heights, New York
EDUCATION: Master of Science in Nursing Family Nurse Practitioner, GSNUniformed Services University of the Health SciencesBethesda, MD1998
Master of Arts in Health Service ManagementWebster University, St. Louis, MO1991
Bachelor of Science in NursingMolloy College, Rockville Centre, NY1986
EXPERIENCE:
1996-1998 Uniformed Services University of the Health SciencesAFIT Student, Masters of Science Degree in NursingFamily Nurse Practitioner Program
1996-1998 Uniformed Services University of the Health SciencesResearch Assistant to Dr. Andre T. DuboisLaboratory of Gastrointestinal & Liver StudiesDigestive Diseases Division, School of Medicine
1994-1996 Nurse Manager Surgery Clinic8 9 th Medical GroupAndrews AFB, MD
1992-1994 Asst. Charge Nurse Intensive Care Unit8 9 th Medical GroupAndrews AFB, MD
1991-1992 Staff Nurse Intensive Care Unit8 9 "h Medical GroupAndrews AFB, MD
(ii)
1987-1991 Staff Nurse Medical Intensive Care UnitWilford Hall USAF Medical CenterLackland AFB, TX
1986-1987 Staff Nurse Emergency DepartmentCity Hospital Center at ElmhurstNew York City, NY
PROFESSIONAL ACTIVITIES AND CERTIFICATIONS:
Nursing Service Management in Residence 1995Squadron Officer School 1993AACN Military Special Interest Consultant 1991CCRN 1990-1996Nurse Flight School 1989National Member AACN 1987-present
PRESENTATIONS:
Helicohacter pylori National NP Symposium 4/98 UMDB, Baltimore, MDHelicohacterpylori USUHS Research Day 4/98 USUHS, Bethesda, MDWartime Triage Medical Readiness Trng 10/96 8 9 th Med Group, AAFB, MDConscious Sedation Nursing Inservice 4/96 8 9 th Med Group, AAFB, MDABG Interpretation Critical Care Course 10/95 8 9 th Med Group, AAFB, MDARDS/Pneumonia CCRN Review Course 1/94 National Navy Med Ctr, MDIschemia/Infarction ICU Monitor Course 10/93 8 9 th Med Group, AAFB, MD
RESEARCH:
Prevalence of Helicobacterpylori in Gastric Fluid in the Surgical Patient 1997(unpublished) Master's Thesis Uniformed Services UniversityFactors related to Medication Errors 1995 (unpublished) Andrews AFB, MDFactors related to Medication Errors 1990 (unpublished) Lackland AFB, TX
AWARDS:
1996 Air Force Commendation Medal1992 Company Grade Officer of the Quarter1991 Air Force Commendation Medal
(iii)
DISCLAIMER STATEMENT
Department of Defense
"This work was supported by the Uniformed Services University of the Health Sciences
Protocol Number T06129-01. The opinions or assertions contained herein are the private
opinions of the author and are not to be construed as official or reflecting the views of the
Department of Defense or the Uniformed Services University or the Health Sciences."
(iv)
COPYRIGHT STATEMENT
The author hereby certifies that the use of any copyrighted material in the thesis entitled:
"PREVALENCE OF HELCIOBACTER PYLORIIN GASTRIC FLUID IN THE SURGICAL PATIENT"
beyond brief excerpts is with the permission of the copyright owner, and will save and
hold harmless the Uniformed Services University of the Health Sciences from any damage
which may arise from such copyright violations.
(v)
ABSTRACT
Helicohacter ipylori is a bacterium that infects the human gastric mucosa. It is well established as
a primary factor in peptic ulcer disease and has been implicated in the pathogenesis of gastric
adenocarcinoma. Surveys consistently show that one half of the world's population carry H.
pylori. H. pylori associated peptic ulcer disease afflicts approximately 10% of the U.S.
population at some point during their lives. Once established, most infections last for decades and
rarely resolve spontaneously. In this descriptive study gastric fluid was collected from 60
asymptomatic patients about to undergo general anesthesia. Gastric fluid was obtained and
cultured to determine the presence of H. pylori. Ten percent cultured positive for the presence of
H. pylori. Data analysis included descriptive and inferential statistics. Results indicated that
culturing gastric juice for H. pylori is a simple, sensitive, and specific method to establish its
presence and that nasogastric aspirates and tubes should be considered as potentially infectious.
The observed 10% positivity for H. pylori within a group of 60 randomly selected military
beneficiaries provides insight into the U.S military population. The prevalence of H. pylori
amongst military members is particularly interesting. The highly mobile nature and frequent travel
puts the American soldier at increased risk for acquisition of this infection. Nurse practitioners
are especially well suited to provide early diagnosis and treatment of infections such as H. pylori
while implementing health maintenance and promotion efforts in order to decrease susceptibility.
This novel approach to obtaining cultures for H. pylori is a cost effective and practical alternative
for establishing the presence of this infection. In addition, knowing the prevalence of H. pylori
among patients receiving care at military facilities will help guide nursing practice in early
detection, treatment and prevention of this prevalent and costly infectious disease.
Key words: Adenocarcinoma, Dyspepsia, Gastritis, Helicobacter pylori, Peptic Ulcer Disease
(vi)
PREVALENCE OF HELICOBACTER PYLORI
IN GASTRIC FLUID IN THE
SURGICAL PATIENT
by
Terence J. McManus BSN, MA, MSN
THESIS
Presented to the Graduate School of Nursing Faculty of
the Uniformed Services University of the Health Sciences
in Partial Fulfillment
of the Requirements
for the Degree of
MASTER OF SCIENCE DEGREE
UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES
May 1998
(vii)
PREFACE
Before I was accepted into the Nurse Practitioner program I had some trepidation over
the challenge of conducting a thesis project. When I entered the Graduate School of
Nursing and was introduced to the faculty and their approach in helping the students
become part of a well planned and supportive nursing research environment I was gladly
relieved and my trepidation quickly dissipated. Right from the start I met encouragement
and support. My research committee chairman, Dr. Monaghan, along with Dr. McMullen
and Dr. Levine provided me with valuable guidance and respect. Their positive attitudes,
ease of communication, and pleasant demeanor offered a nurturing setting for this novice
researcher. Shortly, after starting down the research road I was introduced to Dr. Andre
Dubois, Research Professor and Chief of the Laboratory of Gastrointestinal and Liver
Studies. Dr. Dubois from our first meeting became a mentor of unending enthusiasm and
a champion for my research project. His depth of knowledge and years of research related
to Helicobacterpylori did not overshadow his willingness to welcome me into his
laboratory and provide me with an open door to listen and edify. I owe a special thanks to
Dr. J Mysore for his technical expertise and patience in showing me the methods for
culture and isolation of the bacterium. Family nurse practitioners are a new entity for the
Air Force and the Uniformed Services University. The quality of education that the school
provides and the environment of collaboration shared between the disciplines will allow
nursing research to attain new heights and lead to further contributions by uniformed nurse
practitioner researchers in the future.
(viii)
DEDICATION
To Joanie for her love, support and joy that she brings to my life.
To Ciara and Trevor, my beautiful children, my most valuable gift.
To my parents Thomas and Hannah McManus for their love and upending support.
(ix)
TABLE OF CONTENTSPage
CHAPTER ONE - INTRODUCTION ................................................... I
M icrobiology .................................................................... . . 3
E pidem iology ..................................................... ............ . ... 5
Transmission & Mechanism of Survival ......................................... 6
C linical Syndro m e .................................................................. 8
CHAPTER TWO - REVIEW OF LITERATURE ..................................... 9
C ivilian Populations ...... : ..................................................... . 9
U niform ed Populations ........................................................... 10
CHAPTER THREE - CONCEPTUAL FRAMEWORK .............................. 13
CHAPTER FOUR - METHODOLOGY ................................................ 15
S tu dy P o pu latio n ................................................................... 15
CHAPTER FIVE - DATA ANALYSIS ................................................. 18
A g e ... ...... ......... ............... ...... ... ............ ......... ... ......... ........ 1 9
R a c e ............................................................................ . .... 2 0
E d u c a tio n .............................................................. ............. 2 0
Socioeconomic Status ............................................................ 20
C ro w d ing ............................................................... ... ... .. . .2 1
Limitations . . ...................... 22
CHAPTER SIX - CONCLUSIONS ...................................................... 23
Areas for Further Research ...................................................... 25
R E F E R E N C E S .......................................................................... ... 26
LIST OF APPENDICES ......................................... 31
(x)
LIST OF TABLES
Table 1. Species of the Genus Helicobacter ....................................... 5
Table 2. Helicobacter Pylori Positive or Negative by Age ..................... 19
Table 3. Annual Income of Study Subjects ...................................... 21
Table 4. Number of People Living in the Household Before Age Ten ..... 21
(xi)
Helicobacter pylori 1
CHAPTER ONE - INTRODUCTION
Helicobacter pylori is well established as a primary causative factor in peptic ulcer
disease and has been defined by the World Health Organization as a carcinogen
(International Agency for Research on Cancer, 1994). This bacterium is considered a
pathogen because its presence is always associated with chronic active gastritis, and
eradication of the bacterium is always followed by resolution of the gastritis. In addition,
nearly all patients with duodenal ulcer disease have H. pylori gastritis, and ulcer relapse is
exceptional after H. pylori eradication (Dubois, 1995). Helicobacter pylori infection has
also been associated with persistent diarrhea and increased susceptibility to other
infectious diseases (Clemens et al. 1995). Once established, most infections last for
decades and rarely cure spontaneously, although they usually can be eradicated by
antimicrobial therapy.
Surveys consistently show that approximately one half of the world's population
carry H. pylori. H. pylori associated peptic ulcer disease afflicts approximately 10% of
the U.S. population at some point during their lives and costs billions of dollars per year in
physician fees and medications (Soil, 1993; National Institute of Health Consensus
Development Panel on Helicobacter pylori in Peptic Ulcer Disease Conference [NIH],
1994). In the U.S. and western Europe, children rarely become infected, but more than
half of all 60-year-olds have the bacteria. In contrast, 60 to 70 percent of the children in
developing countries show positive test results by age 10, and the infection rate is even
higher in adults.
The mode of transmission for this infection is not known. Direct interindividual
transmission and/or consumption of food or water contaminated by saliva, gastric
Helicobacter pylori 2
contents, or feces may be a major factor (Ferguson et al. 1993; Thomas, Gibson, Darboe,
Dale, & Weaver 1992; Young et al. 1996). In a study of 934 U.S. Army recruits, Smoak
observed the prevalence of H. pylori to be 26.3% (Smoak, Kelly, & Taylor, 1994). In
addition, Vaira and Hammermeister found that select subgroups of military members are at
particularly high risk for the presence of H. pylori (Hammermeister et al. 1992; Vaira et al.
1991). Knowing the prevalence of H. pylori among the members eligible for military
health care will help guide practice in early detection, treatment, and prevention, enabling
our beneficiaries, active duty, -retirees and dependents, to be at optimal health by
decreasing the risk of infection.
The discovery of H. pylori has changed our concept of peptic ulcer disease from
an acid related releasing condition to one where we can change the course of the disease.
The presence of H. pylori was first seen as early as the late 19th century in animals and
later at the turn of the 20th century in humans, (Dubois, 1995). At the onset of the 20th
century, stress and dietary factors were believed to be related to the pathogenesis of peptic
ulcer disease. The treatment at that time focused on hospitalization, bed rest and special
diets consisting of bland foods. Further theories developed, focusing on digestive
secretions such as gastric acid and their malevolent effects as pathogenic factors in the
development of peptic ulcer disease. As a result antacids became the standard of therapy.
Still later, in 1971, Sir James Black described the histamine H2 receptor that seemed to the
causative link in the production of gastric acid. Histamine receptor antagonists were
developed which have proven to be safe and effective in the treatment of peptic ulcer
disease. Recently, proton pump inhibitors have been shown to be highly effective as acid-
suppressants and as antiulcer therapy (NIH, 1994).
Helicobacter pylori 3
Despite these sophisticated therapeutic agents, the disturbing problem of the high
recurrence rate of peptic ulcer continues, even after complete healing has occurred. (NIH,
1994) It was not until 1983, that Marshall and Warren isolated this then unidentified
curved bacilli in the gastric epithelium of patients with active chronic gastritis. Even then,
it took almost 10 years for the medical community to be convinced of the evidence of a
link between a bacterium and gastrointestinal disease (Marshall and Warren, 1983).
Although their findings seem conclusive, Marshall and Warren's theory was hotly debated
and remained in dispute. The -debate continued even after Marshall and a colleague
performed an experiment in which they infected themselves with H. pylori and developed
gastritis (Marshall, 1996).
Microbiology
The organism was initially named Campylobacter Like Organism (CLO), but later
studies revealed that it did not belong to the genus Campylobacter, and it was renamed
Helicobacter pylori (Blaser, 1996).
"Helicobacter pylori, a microaerophilic bacterium found primarily in the gastric
antrum of humans, appears to be the most common infection worldwide" (Soil, 1993,
p.584). This gram negative bacterium has a curved, spiral, or gull-wing shape. It is 2.5 to
3.5 pim long and 0.5 to 1.0 gim in diameter with a periodicity of I to 2 4tm. Its outer
surfaces are smooth with one to six polar-sheathed flagella emerging from one of its
rounded ends, making it highly motile (Dubois, 1995). It is microaerophilic and, as such,
it grows best at oxygen levels of five percent. This percentage closely matches the oxygen
level found in the stomach's mucous layer. It has an electropositive internal milieu which
Helicobacter pylori 4
helps it to fend off the onslaught of protons in the surrounding medium (Doolittle, 1997).
Its survival in acid conditions depends, in part, on its ability to establish a positive inside-
membrane potential in low pH (Tomb et al. 1997). Helicobacter pylori produces
significant amounts of urease which cleaves urea into ammonia and carbon dioxide. The
presence of urease is one of the biochemical markers used to help identify the presence of
H. /)ylori. (Blaser, 1996).
Helicobacter is a genus composed of at least fifteen species (Table 1) which share
common properties and characteristics. These properties provide the mechanisms that
allow it to survive in the stomach, an ecological niche previously thought to be too
inhibiting for bacteria to endure (Megraud, 1994). "The criterion commonly used to
justify positioning these animal isolates is the sequencing pattern of their ribosomal RNA,
the 16S rRNA gene. This gene is a component of the ribosome which is essential for
protein synthesis," (Lee, 1995, p. 615). Sequencing determines the similarity and
relatedness, between bacteria. Bacteria are considered close relatives if their rRNA
patterns are similar and they can be placed in the same genus if more than 90% of their
patterns match. The different species are thought to have evolved from a common
organism that adapted to inhabit the primordial stomach many years ago (Lee, 1995).
Helicobacter pylori 5
Table I
Species of the Genus Helicobacter
Species Hosts Site
H. pylori' Human, Rhesus monkey StomachH. heilmannii Human, dog, cat StomachH. rappini3 Human, sheep Stomach, liverH. pullorum' Human, chicken StomachH. felis' Cat, dog StomachH. acinonyx' Cheetah StomachH. mustelae' Ferret StomachH. nemestrinae' Macaca nemestrina StomachH. canis' Human, dog IntestineH. cinaedi' Human, hamster IntestineH. fennelliae' Human IntestineH. muridartuni' Mice, rat IntestineH. pametensis' Wild bird, pigH. bills' Mice (Inbred) Intestine, liverH. hepaticits Mice Liver
Note. Adapted from Czinn, 1994; Megraud, 1994; Owen, 1995
Epidemiology
Helicobacter pylori infection of the stomach is the most frequent chronic infection
in the world (McGuigan, 1996). Within the United States there are marked regional
differences in the prevalence of H. pylori infection. The Incidence of infection is highest
in populations in northeastern United States. The Midwest has a moderate incidence of
infection, and the South and West have the lowest incidence (Parsonnet, 1992).
Information about H. pylori is evolving. The following summarizes what is known:
Helicobacter pylori prevalence increases with age
Helicobacter pylori 6
"* The infection is more prevalent in lower socioeconomic groups
" Crowded living conditions, such as institutions, increases the incidence and
prevalence of this infection
" When socioeconomic factors are controlled for, African Americans and
Hispanics have higher infection rates than Caucasians
"* More than 50% of cases are acquired in childhood and adolescence
" The risk and rate of acquisition is highest in early childhood, after which the
rate exponentially declines (Sipponen, 1997)
" Human-human transmission occurs often. In Canadian and American families,
the mother and siblings of an infected child have a 75-80% risk of being
infected. The risk in the general population is about 20%
" Infection rates are extremely high in Saudi Arabia, Asia, Albania, parts of
Africa, and South America. In most developing countries, the majority of the
population is infected by early adulthood (Cerda, Go, Loeb, & Westblom,
1994)
Transmission & Mechanism of Survival
The mode of transmission remains unknown, although either an oral-oral or a
fecal-oral route is likely, so far studies have not been conclusive (Vaira et al. 1991). An
interesting study reported by Moshopoulos and Skandalis (1996), examined sixty-four
patients with duodenal ulcers and found 78% of the spouses of patients (N=42) positive
for H. pylori were positive as well. Compared with 20% for the partners of the H. pylori
Helicobacter pylori 7
negative group(N=10), suggesting person to person transmission within couples or
exposure to a common source of infection.
How H. pylori survives and acts on the stomach has been a matter of intense
research. In the human stomach copious amounts of hydrochloric acid are produced and
the pH is maintained at <2. Most bacteria cannot survive in such a low pH. When H.
pylori enters the gastric lumen it is immersed in acidic gastric juice where small amounts
of urea are present. Helicobacter pylorl produces urease which breaks down the urea and
produces ammonia. The ammonia, which elevates the pH, is produced in a cloud around
the bacterium. This helps to protect the organism from the harsh acidic environment.
Once in the stomach H. pylori embeds itself in the mucous layer that covers the gastric cell
surface (Lee & Mitchell, 1994). "The pH at the gastric epithelial cell surface is believed to
be neutral. Urease activity, at this level, may still be an important factor in continued
long-term survival by enabling the bacterium to utilize urea as a nitrogen source" (Owen,
1995, p.428).
Almost 80% H. pylori live in the mucus layer of the infected hosts, while
approximately 20% adhere to the mucosal epithelial cells using adherence pedestals
(Owen, 1995). These adhesion pedestals, in turn, may attract neutrophils and generate an
antibody response. It is this local inflammatory reaction that is thought to nourish the
bacterium. Different strains produce different cytotoxins which, along with the urease
produced, may contribute to the mucolytic changes that occur (Soil, 1993). Two
phenotypic traits are characteristic of nearly all strains from persons with peptic ulcer
disease or gastric cancer and are missing from many of the strains from asymptomatic
carriers. The first is called VacA, a cytotoxin that produces prominent vacuoles in
Helicobacter pylori 8
cultured eukaryotic cells. The second is a large protein called CagA, a protein that is
produced by most toxigenic strains, and not produced by most non-toxigenic strains.
(Covacci et al. 1993: Cover, Dooley, & Blaser, 1992; Figura et al. 1989; Fox et al. 1992;
Tummuru, Cover, & Blaser, 1993)
Clinical Syndrome
Helicobacter pylori contains and expresses an assortment of proinflammatory
biomolecules. These biomolecules stimulate host cells to release proinflammatory
substances which participate in the initiation and perpetuation of inflammation and tissue
injury (McGuigan, 1996). The clinical syndrome of acute Helicobacter infection appears
to be one of epigastric cramping pain, nausea, vomiting, flatulence, malaise. In some cases
there may be a fever, and mucousy vomiting may also be present. The incubation period is
from 1-7 days and may or may not be followed by a dyspeptic syndrome. These symptoms
will last for about a week and then disappear, whether or not the organism has been
spontaneously eliminated. The organism usually persists after initial infection, but may
disappear spontaneously. There is an initial IgM response which declines, to be followed
by IgG conversion; this persists unless the organism is partially or completely eradicated.
(Axon, 1994)
Asymptomatic individuals may have many symptoms which remain hidden. The
bacteria may have different virulence factors or host factors that may determine the
consequences of infection (Axon, 1994). The prevalence of this infection in many
populations is still unknown.
Helicobacter pylori 9
CHAPTER TWO - REVIEW OF LITERATURE
Civilian Populations
Staat and colleagues were the first to investigate H. pylori US population based
prevalence. They demonstrated that even in developed countries, such as the USA, H.
pylori is acquired in early life (Staat, Kruszon-Moran, McQuillan, & Kaslow, 1996). The
team determined the prevalence of H. pylori infection in 2581 children between 6-19 years
old by measuring anti-H. pylori IgG antibody concentrations. The researchers found that
24.8% of participants had evidence of Helicobacter infection. Infection was strongly
associated with increasing age and ethnicity. Seventeen percent of non-Hispanic whites
were infected, compared with 40% of non-Hispanic blacks, and 42% of Mexican
Americans (Staat, 1996).
In the Staat study, the infection rate was higher among children from low-income
families. The education level of the head of the household was also an important predictor
of infection. Among Mexican Americans, birth outside the USA and Canada was an
important independent risk factor for infection with H. pylori (Staat, 1996).
In Poland, Matysiak-Budnik et al. (1996) studied a group of 656 asymptomatic
individuals ranging in age from 0-85 yrs. The overall rate of infection for all individuals
was 73% versus 87% for those over the age of twenty. In addition there was an 18%
seropositivity rate in those less than five years old as compared to 80% for those between
the ages of 20 and 25. For the oldest group born between 1910 and 1970, the rate was
between 80 and 100%. Ten percent of the Polish population has Peptic Ulcer disease and
an incidence of gastric cancer on average of 36 per 100,000 inhabitants per year for men
Helicobacter pylori 10
(Matysiak-Budnik et al. 1996). This is of particular interest to US military members living
or deployed to central Europe.
The highest rates of H. pylori infection occur in, areas with the highest rates of
stomach cancer, such as China, Japan, Peru and Scotland. However, even in the US,
certain populations have higher rates of gastric cancer. In New Orleans, 70 percent of
blacks are infected with H. pylori, and the gastric cancer rate in this population is 43 cases
per 100,000 population. In whites living in New Orleans, the infection rate is about 43
percent, and the gastric cancer rate is 10 cases per 100,000 (Correa et al. 1990). In a
recent report by Kennedy and Mahoney (1997), H. pylori was linked to sickle cell disease
and recurrent abdominal pain in children. A new effort has begun to look at H. pylori in
children and the effects of this infection on growth and development.
Uniformed Populations
Smoak and colleagues studied the seroprevalence of H. pylori infections in a
cohort of US Army recruits (Smoak, Kelley, & Taylor, 1994). Sera were collected from a
nationwide sample of 404 females and 534 males at induction into the US Army at Fort
Jackson, South Carolina, during the fall of 1990. The purpose of the study was to
determine the prevalence and examine risk factors of H. pylori infection in healthy young
adults in the United States. The mean age of this group was 20.2 and the range was 17-26
years. Overall, this study found the H. pylori seropositivity rate in healthy young adults to
be 20.8 percent. Age and ethnicity were strong predictive factors for H. pylori infection
as well as living in an urbanized county of more than 1000 persons per square mile.
Seropositivity rates nearly doubled from the youngest to the oldest age groups. Women
Helicobacter pylori II
of all races had higher infection rates than did men. Among Hispanics, 52% of the females
and 26% of the males were infected. The overall rate of positivity was 44% in blacks,
38% in Hispanics and 14% in whites (Smoak et al. 1994).
A study was done by Vaira and colleagues (1991) of 137 Italian soldiers living in a
military barracks in Bologna, Italy. These soldiers were compared to 118 blood donors
residing in the same country. The mean age of the soldiers was 20 years, similar to the
blood donors mean age of 22.8. Forty six out of 137 (33.6%) of the soldiers had
antibodies to H. pylori compared to thirteen of 118 (11%) of the blood donors. The
soldiers had been living in the barracks for six months. The results indicate a higher
prevalence of H. pylori antibodies in the military adults compared to the blood donors
from the general population. The hypothesis that H. pylori infection is acquired by close
personal contact between individuals is supported by this data.
Hyams et al. (1995) found almost a 2% yearly H. pylori seroconversion rate from
a cohort study of 601 US military soldiers deployed for six months to South America,
West Africa, the Mediterranean, or Saudi Arabia. This is approximately four times the
rate for the general US population. This increased risk may result either from exposure to
a high risk environment for H. pylori infection in enteric endemic areas or from crowding.
Hammermeister, et al. (1992) investigated the seroprevalence and incidence of H.
pylori in submarine crews over a one year period. Sixty-four German submarine crew
members were serologically compared to a group of fifty-four German Air Force staff.
The results demonstrated a marked increase in seropositivity for the Submarine crews
(39.1%), as compared to 18.9%. for the Air Force staff. The author concluded that
Helicobacter pylori 12
submarine crews serving their missions in an overcrowded space with extremely limited
sanitary facilities must be considered a high-risk group for H. pylori.
Helicobacter pylori 13
CHAPTER THREE -CONCEPTUAL FRAMEWORK
The relevant theoretical perspective chosen for this study was derived from
Akinsanya's model of bionursing. The purpose of this theory was to develop a link
between nursing and the life sciences (anatomy, physiology, microbiology and
pharmacology), separate from the traditional link through medicine (Akinsanya 1987b,
Casey 1996). Akinsanya argues that since most disciplines which utilize knowledge from
the biological sciences prefix their terms with 'bio' (biomedical, biophysics, bioethics, etc),
the use of the biological sciences in the teaching and practice of nursing should thus be
termed bionursing. The direct link between bionursing and nursing care describes the
impact that bionursing has on clinical practice by giving it the rationale for the tasks of
nursing. It also examines the bioscience knowledge base required in the performance of
required nursing tasks. This is where the bulk of Akinsanya's empirical work lies. He
observed nursing activities and asked nurses what type of science knowledge they needed
for the performance of those observed tasks (Akinsanya, 1987a). This thesis will draw
directly from the knowledge of the sciences of microbiology , physiology, and
pathophysiology. All of these branches of science will be brought together in unison at the
completion of this bionursing research project.
Air Force family nurse practitioners will be utilized as health care providers
throughout military facilities. As such, they will need to be kept up to date on new
therapeutics, new techniques in patient management and areas of current research.
Mastered prepared nurse practitioners will have the theoretical knowledge as well as the
practical knowledge to assess research problems. They will be able to approach these
problems from a firm foundation in the biological sciences. This will supply the health
Helicobacter pylori 14
care community with solid bionursing research that can be added to the scientific
knowledge base of the medical community as a whole.
Nurse practitioners will also play a pivotal role in health maintenance and disease
prevention. Epidemiological data obtained through research concerning different
populations will support the diagnostic role of the nurse practitioner. Knowing the risk
factors for H. pylori and being aware of current research in this area will help provide
nurse practitioners with the knowledge to structure military environments in such a way as
to diminish the risk of transmission of this infectious disease.
Helicobacter pylori 15
CHAPTER FOUR - METHODOLOGY
This research is a descriptive study designed to determine (1) whether gastric juice
is a possible source of transmission of H. pylori and (2) the prevalence of H. pylori in
surgical patients. It is an extension of a study conducted by K.A. Young and colleagues
(1995) using a different population. Participants were patients who were scheduled to
undergo surgery as part of their medical management and who were to receive a naso-
gastric tube as part their care.
The participants consisted of a convenience sample from the 8 9 th Medical Group,
Malcolm Grow Medical Center, Andrews AFB. Institutional Review Board (IRB)
approval was obtained from the Uniformed Services University of Health Sciences
(USUHS) as well as from the 8 9 1h Medical Group Institutional Review Board. The study
was desogned to utilize a sample size of 50 patients which was later extended to 60.
Study Population
Criteria for selection/inclusion:
The patients were greater than 18 years of age, hospitalized, scheduled to have
surgery and were anticipated to receive a nasogastric or orogastric tube as part of their
surgical management. There was no restriction for entry based on gender, physical or
psychiatric condition other than the ability to give informed consent. A total of 60
patients were enrolled in the study over a six month period. The sample size was
determined through power analysis using a small effect size of 0.34, a power of .80 and a
level of significance of .05 (Burns, 1993).
Helicobacter pylori .16
Criteria for exclusion:
1. Inability to sign informed consent
2. Age less than 18 years
3. continuous tube feedings
4. Receiving one or more of the following medications
Bismuth
Clarithromycin
Metronidazole
Tetracycline
Amoxicillin
Proton pump inhibitors (i.e. Omeprazole)
Patients were selected by the investigator after consultation with the attending staff
physician, thereby ensuring preservation of patients rights and avoiding any pressure to
participate in the study. Patients received a coded research number which was used for
sample identification to protect patient confidentiality.
After patients were identified as meeting the research criteria, the research
protocol was explained and written consent obtained. Once informed consent was
obtained, the patient received general anesthesia with subsequent placement of either a
nasogastric or orogastric tube (GT). Upon confirmation of placement of the GT, 4 to 50
mL. of gastric fluid was aspirated using sterile techniques and a sterile 60 mL. catheter tip
syringe. The fluid was then transferred to a sterile specimen tube where phenol red was
added to the fluid until a yellow color appeared and then the pH was tested. Sodium
Helicobacter pylori 17
bicarbonate, 7.5%, was titrated to the sample until a pH of seven was obtained (red color).
The fluid was sealed, placed on wet ice and later taken to the laboratory of
Gastrointestinal and Liver Studies at USUHS for culture. A 200 uL aliquot of the fluid
was streaked on Campylobacter chocolatized agar plate supplemented with trimethoprim,
vancomycin, amphotericin B, and polymyxin B and incubated at 37'C in an atmosphere of
90% N2, 5% 02, and 5% CO2. Presence of H. pylori was identified as forming pinhead-
sized water spray colonies within 7-10 days, have urease, oxidase and catalase activities,
and seen by microscopy as Gram-negative curved or "gull wings" rods. Gram stain
morphology was confirmed by an expert in H. pylori research.
Data analysis includes predominantly the use of descriptive statistics to report the
presence of H. pylori in the gastric fluid in this population. Additionally, demographic
data allows for description of the sample and permits comparisons between groups based
on demographic characteristics.
Helicobacter pylori 18
CHAPTER 5 - DATA ANALYSIS
After receiving approval from the Institutional Review Board (see Appendix A &
B), gastric fluid was obtained from a convenience sample of patients following informed
consent. These volunteers were pre-scheduled to have general anesthesia for surgery at a
medium-sized military medical facility. Summary measures such as percentages were used
to describe the sample.
Fresh gastric fluid samples were obtained from patients undergoing surgery for a
variety of reasons. Participation was based on ability to understand and sign the consent
form, age greater than eighteen, and no evidence of use of amoxicillin, clarithromycin,
metronidazole, bismuth, or antisecretory agents within the last twenty-four hours. Once
informed consent was obtained, the gastric fluid was aspirated, neutralized, sealed and
placed on wet ice and later taken the laboratory for analysis.
When a subject was found to be positive, notification in the form of a letter,
(Appendix L), was given to the subject's staff surgeon. In addition, if a participant
requested to know their status, positive/negative, a phone call or letter was given to the
participant with the culture results.
A total of sixty gastric fluid samples were obtained from the study subjects who
consisted of 55% females and 45% males. The age range was nineteen to seventy-five
years, with a mean age of thirthy-three. From the samples of gastric fluid 10% were
determined to be positive for H. pylori by culture. There were eighteen active duty
members and one of them was positive for H. pylori. The other positive participants were
two dependents and three retirees.
Helicobacter pylori 19
A culture was defined as positive if:
1. Growth had the typical "water-spray" appearance
2. Colonies were positive for catalase, oxidase, and urease
3. Bacteria were Gram negative and had a curved rod morphology
The amount of gastric fluid obtained ranged from 2mL. to 50mL. The average
amount of gastric juice aspirated was 16.5mL. For the six subjects that were positive the
range of gastric fluid aspirated was 3mL. to 38mL., the average being 16.8mL. One-third
of these samples were less than 1OmL. This is in contrast to the findings of Young
(1997), who found H. pylori positive fluid only in samples that were greater than IOmL.
Age
The average age of those infected was forty-four, with a range of twenty-seven to
sixty-six (Table 2).
Table 2
Helicobacter pylori Positive or Negative by Age
Age Positive for HP/Total (N) Percent Positive
22-40 2/18 11%
41-60 3/25 12%
61-80 1/17 6%
Total 6/60 10%
Helicobacter pylori 20
Race
The ethnic background of the sample population was as follows: Thirty-nine (65%)
were Caucasian, fifteen (25%) Afro-American, four (7%) Asian, and two (3%) were
Hispanic. Of those that were positive three (50%) were Caucasian, two (33%) were
African-American, and one (16%) was Hispanic. Two of the six (33%) that were positive
for H. pylori, (one Hispanic, one Caucasian),were born outside of the United States,
Education
Seventy percent (45) of the sample population had completed high school. While
fifteen (25%) had less than twelve years of schooling, five (8%) had greater than sixteen
years of education. Among those who were H. pylori positive, five (83%) had completed
high school but none had been to college.
Socioeconomic Status
Socioeconomic status was divided into three categories, those earning less than
50,000 dollars per year, $50,000 to $100,000 dollars per year, and those earning greater
than $100,000 dollars per year. Fifty-three percent (32) earned less than $50,000 dollars
per year. 38% (23) earned $50,000-$100,000 dollars per year, and eight percent (5)
earned more than $100,000 per year. Among the six who were positive for H. pylori half
(3) earned less then $50,000 dollars per year, one earned $50,000 to $100,000 per year
and two earned more than $100,000 per year (Table 3).
Helicobacter pylori 21
Table 3
Annual Income of Study Subjects
Annual Income Positive for HP/Total (N) Percent Positive
Less than $50,000 3/32 9%
$50,000 - $100,000 1/23 4%
More than $100,000 2/5 40%
Total 6/60 10%
Crowding
Higher frequency of testing positive for Helicobacter pylori has been found in
people living in crowded conditions (Dubois,1995). Sample population participants were
asked how many people lived in their household before they reached the age of ten. For
the sample population, 22% of the sample had a household size of _> 7 people while 5%
had a household size was 3-6 people, (Table 4).
Table 4
Number of People Living in Household before Age Ten
Number Positive for HP/Total (N) Percent Positive
1-6 2/42 5%
7 or greater 4/18 22%
Total 6/60 10%
Helicobacter pylori 22
Limitations
Although sample size was ample for the scope and aim of this study, it is difficult
to perform statistical analysis since only six subjects were found to be positive for H.
pylori. Gastric fluid culture is a novel method for isolating H. pylori and the rate of
positivity might have been enhanced with collection of either endoscopic gastric biopsies,
serology or breath testing. The nature of the surgical patient with frequent pre-operative
and/or recent use of antibiotics could have been a factor in the number of negative
cultures; however it is important to note that none of the subjects positive for H. pylori
received preoperative antibiotics while 11 of the H. pylori negative were treated with
preoperative antibiotics. Other factors such as the position of the nasogastric tube and the
possible dilutional effect of such pre-medications as Bicitra®, sodium bicarbonate, could
also have contributed to a lower yield of positivity. However the pH of gastric juice
sampled 1-3 hours after Bicitra® administration was not different from the pH in subjects
who did not receive Bicitra®. The use of sodium bicarbonate could potentially have led
to a rebound in acid production with subsequent lowering of the gastric pH. Although the
gastric juice was immediately neutralized and placed on ice there was a delay of unknown
duration between rebound acid secretion following Bicitra® administration
Helicobacter pylori 23
CHAPTER 6 - CONCLUSIONS
Prevalence of H. pylori infection increases with age and varies among racial
groups in the United States. Approximately 10 percent of Caucasians below the age of 35
are infected with H. pylori, increasing by 10% for each subsequent decade of life.
Prevalence is higher among African-Americans where 45 percent of those 25 years of age
or less are infected (Damianos & McGarrity, 1997). The results of this experiment are in
agreement with these epidemiological data. The observed 10% positivity for H. pylori
within a group of 60 randomly selected patients undergoing general anesthesia for
scheduled surgery, provides insight into the U.S. military population. This study confirms
that for military surgical patients within the continental United States, the prevalence of H.
pylori is similar to that of the population of the nation as a whole.
This study examined gastric fluid and found similar results than previous studies
using gastric biopsy, the gold standard for determining the presence of H. pylori.
Culturing gastric juice for H. pylori is a simple, sensitive and specific method to establish
the presence of H. pylori. In an article that was published after this study was initiated,
Mokuolu (1997) found similar results measuring gastric juice urease activity in 57 patients
and finding gastric juice urease activity to be a reliable, inexpensive and readily available.
The prevalence of H. pylori amongst military members is particularly interesting.
The highly mobile nature and frequent travel to often harsh environments puts the
American soldier at particular risk for acquisition of this infection.
Nurse practitioners are particularly well suited to provide early diagnosis and
treatment of infections such as Helicobacter-pylori while implementing health maintenance
and promotion efforts in order to decrease incidence of the infection. The term
Helicobacter pylori 24
Bionursing as envisioned by Askansazi is the incorporation and utilization of those core
courses required for nursing education such as Physiology, Biochemistry, Pathophysiology
and Microbiology in order to enhance the breath of knowledge of nurses while providing a
broad scientific background leading to well-grounded nursing research. This study drew
from these core disciplines and demonstrated an example of Bionursing research. These
branches of science were brought together in unison at the completion of this study and
have led to further questions as well as continued research by the investigator.
Nurse practitioners, nurse researchers, and other health providers armed with up to
date epidemiological information related to areas of deployment as well as permanent
foreign base sites are positioned at the forefront of the fight against infectious disease.
Mastered prepared nurse practitioners have the theoretical knowledge as well as the
practical knowledge to assess research problems, approaching such problems from a firm
foundation in the biological sciences. In order to prevent such diseases as H. pylori, it is
essential to clarify its epidemiology and mode of transmission. The results of this study
demonstrate that nasogastric aspirates and tubes should be considered as potentially
infectious
Research related to H. pylori has exploded after Warren and Marshall (1983) first
reported a link between these curved microscopic organisms now called H. pylori, and
chronic gastritis. Although nearly fifteen years have passed since that report, the research
effort continues with great enthusiasm. Researchers are delving into every aspect of the
nature, the mode of transmission, the genetic make-up, and the chemistry of Helicobacler
pylori and its impact on humans.
Helicobacter pylori 25
Areas for Further Research
Helicobacter pylori provides for an exciting area of research. There are
many unanswered questions related to mode of transmission, virulence, carcinogenicity
and why some populations seem to be inherently predisposed to this infection. The recent
sequencing of the H. py/ori genome is sure to lead to further discoveries and to further
questions. One of the benefits of the present study is that the H. pylori strains isolated
from this population will be typed for the presence of virulence factor (cagA). This will
provide insight into the type of bacteria present in a very special population that is not
generally studied, and may represent the majority of uniformed personnel. Likewise, the
effects of deployments and the close living arrangements that are often found while
deployed offer an excellent opportunity for discovering some of the answers to this
puzzling disease and potentially provide methods to prevent its transmission. Studies
involving submariners, during long missions, as well as astronauts, on prolonged space
flights. may provide good models for military personnel restricted to close quarters.
Furthermore, conducting a study with a larger sample size at other military facilities using
gastric fluid. sera, tissue samples or the newly FDA-approved breath test for H. pylori can
be fertile ground for further research. Another area that is just beginning to be explored is
the mode of transmission of H. pylori to children and its long term effects on growth and
development: a particularly interesting area for Family Nurse Practitioners.
Helicobacter pylori 26
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Helicobacter pylori 31
LIST OF APPENDICES
A. IRB Approval Letter: Uniformed Services University
B. IRB Approval Letter: 8 9 "h Medical Group
C. Medical Law Consultant Approval Letter: 89th Medical Group'
D. Memorandum to USU IRB for Funding
E. Notice of Fund Approval: Director of Grants Administration
F. Notice of Fund Approval: Vice President for Research
G. IRB Approval Letter: 8 9 th Medical Group - Study Extension
H. Consent Form Approval: USU IRB
I. Data Collection Form
J. Staff Physician Notification Letter for Participants Positive for Helicobacter pylori
• rYUF~i •ILT'H SC1IENCES4301 JONES BRIDGE ROAD
BETHESDA, MARYLAND 20814-4799
May 14, 1997
MEMORANDUM FOR TERENCE J. MCMANUS, GRADUATE SCHOOL OF NURSING
SUBJECT: IRB Approval for Protocol T06129-01 Involving Human Subject Use
The new protocol entitled "Prevalence of Helicobacterpylori in Gastric Fluid in the
Surgical Patient" received an expedited review on 5/9/97 and was APPROVED by Edmund G.
Howe, M.D., J.D., Chairperson, Institutional Review Board on 5/9/97. This protocol isconsidered to be not greater than minimal risk in accordance with 32 CFR 219.110 (8). This is a
descriptive study to ascertain the incidence of Helicobacter pylori in surgical patients. Subjectswill be randomly selected volunteers who are scheduled to have a surgical procedure where
introduction of a nasogastric tube is anticipated. Up to fifteen ml of gastric fluid, normallydiscarded, will be removed from the patient's stomach through the nasogastric tube, frozen, and
sent to USUHS for analysis. Approval from Malcolm Grow IRB where study will be conductedalready received.
The consent form approved for use is attached. It is your responsibility to review and
maintain an accurate and accessible file of all consent forms used in this study for each study
site. This research study will be reviewed within one year of this date, unless otherwisecompleted.
Please notify this office of any amendments you wish to propose and of any adverse
events which may occur in the conduct of this project. If you have any questions regarding
human volunteers, please call me at 301-295-331.
Mi hael J. McCreery, h.D.LTC, MS, USADirector, Research Programs andExecutive Secretary, IRB
Attachments:A/S
ýTý :ZP'C":e-1 Pacer
HlEADQUARTERS 89TI1 AIRLIFT WING (AMC)
1947 - 1997
18 Feb 97
MEMORANDUM FOR CAPTAIN TERRY McMANUS
FROM: 89 MDG/SGI
SUBJECT: Approval of Protocol: Prevalence ofHelicobacter pylori in Gastric Fluid
1. The Institutional Review Board following both a technical and ethical review approved youprotocol at its 12 Feb 97 meeting. You may begin your study.
2. Please ensure all required reports and copies of informed consent documents are forwarded tothis office promptly.
ISADORE NEUROCK, DDSDirector of Medical Education
itlden C.!C,,l 3oundless Future... w Your Natilon'' ,Air Force
HEADQUARTERS 89TH AIRtiFF WING (AAMC)
1947- 1997
11 February 1997
MEMORANDUM FOR SGI
FROM: SGJ
SUBJECT: Research Protocol "Prevalence of Helicobacter pylori in Gastric Fluid,Captain Terence J. McManus, USAF, NC
1. I have reviewed the above mentioned protocol and find the informed consentdocument does not require the witnesses SSN number. On page 2 of 3 of theinformed consent para 12, please change the word "he" to "she".
2. I also recommend adding the following paragraph found in Chapter 3 of AFI 40-404(Para 3.1.6.1.), "Any medical misadventure or unanticipated medical event will bebrought immediately to the attention of the subject, or the subject's guardian or nextof kin, if the subject is not competent at the time to understand the nature of themisadventure or unanticipated medical event."
3. Please add paragraphs (g) regarding the Privacy Act Statement - Health Care Recordsand () the voluntary participation statement of Attachment 4 of AFI 40-403.
4. After the above mentioned changes have been made this informed consent willcomply with the requirements set out in AFI 40-403. 1 do not need to review thedocument once the modifications are made. I recommend its approval.
MARYALICE DAVID, Capt. USAFMedical Law Consultant
AttachmentProtocolPortions of AFI 40-403
Golden Legacv, Boundless Future... Your Nation's Air Force
25 Feb 97
MEMORANDUM TO: USUHS IRBAtt.: LtCol McCreery
SUBJECT: Funding for (Budget Request) USUHS Intramural Research Protocol
FROM: Capt Terry McManus
1. CONSUMABLE SUPPLIES:
1. 80 Chocolatized Campy Blood Agar plates at a cost $3.30 each for a total of$264, for the initial isolation of the Helicobacter pylori bacterium from thegastric fluid. ($264)
2. 80 Blood Agar plates at a cost of $1.10 each for a total of $88, for the furtherisolation of the Helicobacterpylori bacterium.
($88)3. Chemicals, pipettes, reagents, gas for incubator, pH paper, and general
laboratory supplies $350. ($350)
2. OTHER COSTS:
Photocopying, paper, and computer costs for data entry $48. (1481($750)
Total budget request $750.
3. Thank you for your consideration.
Terence J. McManus, Capt, USAF, NCFamily Nurse Practitioner StudentGraduate School of Nursing
S~BETHESDA, MARYLAND 20814-4799
July 29, 1997
MEMORANDUM FOR TERENCE J. McMANUS, GRADUATE SCHOOL OF NURSING
SUBJECT: Notice of Fund Approval (T06129-01)
Attached is the Notice of Fund Approval for the above referenced graduate nursing
student project. Funds have been authorized as shown.
If you have any questions or concerns, please contact Michael P. Giza in the Offce of
Research at 295-9815.
Beth BowdenDirector, Grants Administration
Attachmentcc:Dean, GSN
•"•'•C2" • "ecvcrec Pooe'
4301 JONES BRIDGE ROADBETHESDA, MARYLAND 20814-4799
July 29, 1997
NOTICE OF FUND APPROVAL*Change No.:Original
Project No: T06129-01Principal Investigator: Terence J. McManusProject Title: Prevalence of Helicobacter Pylori in
Gastric Fluid in the Surgical Patient
Project Period: From. 4/ 1/97 Through 9/30/97Budget Period: From 4/ 1/97 Through 9/30/97
TYPE OF EXPENSE BUDGET
1. Personnel Support ... ............ .. $02. Supplies/Equipment/Other Expenses . . .. $5003. Travel ........ .................. .. $0
TOTAL .... ............. .. $500
*Fund approval is contingent upon the appropriation of funds to USUHS.Travel (except that which is an approved part of the project) may notbe charged to the project. Major equipment with unit cost equal toor greater that $5,000 will be charged against separate funds.
Funding Accomplished Zf-4L7 Budget Officer _/_____.___
Questions regarding this award may be directed to the Office of Research
SRuth Ellen Bulger, Ph.D.Vice President for Research
Pf-nec on R •ecycied Paper
19 Sep 97
MEMORANDUM FOR Captain Terry McManus
FROM: 89 MDG/SGI
SUBJECT: Extension of Helicobacter Study
I. The Institutional Review Board (IRB) Committee approved the extension of theprotocol "PREVALENCE OF HELICOBACTER PYLORI IN GASTRIC FLUID IN THESURGICAL PATIENT" on 10 Sep 97.
2. Please ensure all progress and final reports are forwarded to my office promptly.
WILLIAM H. AUSSIKER, Col, USAF, DCDirector, Career Development Function
APPROVED FOR USE Pg 1 of 3
DATE I/,"II17---- Date:N89th Medical Group
INITI/IAl."DW S AFB, MARYLAD
Consent for untary Participation in a Clinical Investigation Study
1. I, , have been asked to'yoluntarily participate in a researchproject entitled, "Prevalence of Helicobacter pylori in Gastric Fluid in the Surgical Patient" beingconducted at the 89th Medical Group, Andrews AFB, Maryland.
2. The 2rocedure for this project involves: Analyzing gastric fluid that is normally discarded.Removing 10-15 mL. of this fluid from my stomach from a tube that will be in my nose, mouth orstomach. Removal of small amounts of gastric fluid is part of the normal nursing procedure formaintenance of these tubes. This tube will be airtady be in place related to my medical managementand will not be placed specifically for this study. I understand that this procedure is not painful andwill not have any effect on my medical or surgical condition.
3. The purpose of this research proiect is to: Determine the presence of the bacteria, Helicobacterpylon, in stomach fluid in patients who have been admitted to an intensive care unit. Helicobacterpylon is an organism that has been found to be a factor in some forms of stomach inflammation andspecific types of ulcers. Humans are at increased risk for becoming infected with this bacteria as theyage. Many people are infected with this bacteria and have no symptoms. Many questions remainunanswered regarding this bacteria, such as how do people become infected, why do some people havesymptoms while others do not, and where in the body can this bacteria be found.
4. A total of 50 subjects are expected to participate in this project.
5. The risks or discomforts during the removal of the stomach fluid include clogging of orunintentional removal of the tube.
6. I understand that the research may or may not help me personally but that the results may help theinvestigator learn about the prevalence of Helicobacter pylon in stomach fluid in patients admitted toan intensive care unit. It is expected that this information will lead to further research related toHelicobacter pylon prevalence and presence in gastric fluid. At this time the presence of Helicobacterpylon in patients who do not have symptoms is not an indicator for treatment to remove the bacteria.If at a later time, it is determined that I have peptic ulcer disease, the information regarding myHelicobacter pylon status will help the physician in the treatment of my condition.
7. 1 understand that I may withdraw from this study at any time without prejudice to my future care. Iunderstand that if I withdraw from this project, I will not lose any benefits to which I am otherwiseentitled.
8. 1 have been informed that there will be no additional costs to me beyond those normally associatedwith my care at the 89th Medical Group, Andrews AFB.
I understand and accept these risks. Subject/Patient Initials
! !11,
pg 2 of 3
9. Any new significant finding developed during the course of the research which may effect mywillingness to participate further will be explained to me.
10. In all publications and presentations resulting from this research project, my anonymity will beprotected to the maximum extent possible; however, I realize that authorized Air Force MedicalDepartment personnel may have access to my research file in order to verify that my rights have beensafeguarded.
11. If I suffer any physical injury as a result of my participation in this study, immediate medicaltreatment is available at the 89th Medical Group, Andrews AFB, Maryland. I understand that althoughno compensation is available, any injury as a result of my participation will be evaluated and treated inkeeping with the benefits or care to which I am entitled under applicable regulations.
12. Any medical misadventure or unanticipated medical event will be brought immediately to theattention of the subject, or the subject's guardian or next of kin, if the subject is not competent at thetime to understand the nature of the misadventure or unanticipated medical event.
13. If I have any questions regarding this research project, I may contact Captain Terry McManus at301-599-6554. If I have any questions regarding my rights as an individual while participating in aresearch project at the 89th Medical Group, Andrews AFB, I can contact the Medical Legal ConsultantCaptain David at (301) 981-4440. She will answer my questions or refer me to a member of theCommittee for the Protection of Human Subjects for further information. If I believe I have beeninjured as a result of this project I may call the legal office (301) 295-2215.
14. 1 understand that my participation in this project is voluntary and that my refusal to participatewill involve no penalty or loss of benefits to which I am entitled under applicable regulations. If Ichoose to participate, I am free to ask questions or to withdraw from the project at any time. If Ishould decide to withdraw from the research project. I will notify Captain Terry McManus at 301-599-6554. to ensure an orderly termination process. My withdrawal will not involve loss of benefits towhich I am entitled.
I certify, that I have received a copy of this consent form.
Date Signed Patient/Subject Signature
Printed Name-Status-Sponsor's SSN
Witness' Signature & Date Investigator Signature & Date
Witness' printed Name- Investigator printed Name-Rank-SSN
pg 3 of 3
PRIVACY ACT STATEMENTS
1. Authority. 5 USC 301
2. P=ose. Medical research information will be collected to enhance basic medical knowledge, or
to develop tests, procedures, and equipment to improve the diagnosis, treatment, or prevention of
illness, injury or performance impairment.
3. Use. Medical research information will be used for statistical analysis and reports by the
Departments of the Air Force and Defense, and other U.S. Government agencies, provided this use is
compatible with the purpose for which the information was collected. Use of the information may be
granted to non-Government agencies or individuals by the Surgeon General in accordance with the
provisions of the Freedom of Information Act.
4. sclosure. I understand that all information contained in this Consent Statement or derived from
the experiment described herein will be retained permanently at 89th Medical Group, Andrews AFB,
Maryland and salient portions thereof may be entered into my health record. I voluntarily agree to its
disclosure to agencies or individuals identified in the preceding paragraph and I have been infornnu
that failure to agree to such disclosure may negate the purposes for which the experiment was
conducted.
5. Records. Records of my participation in this study may only be disclosed in accordance with
federal law, including the Federal Privacy Act, 5 U.S.C. 552a, and its implementing regulations. DD
Form 2005, Privacy Act Statement-Health Care Records, contains the Privacy Act Statement for the
records. I understand that records of the study may be inspected by the US Food and Drug
Administration (FDA).
6. Voluntary Decision. The decision to participte in this study is completely voluntary on my part.
No one has coerced or intimidated me into participating in this program. I am participating because I
want to. Captain McManus has adequately answered any and all questions I have about this study, MiY
participation, and the procedures involved. I understand that Captain McManus will be available to
answer any questions concerning procedures throughout this study. I understand that if significant nem
findings develop during the course of this study which may relate to my decision to continue
participation. I will be informed. I further understand that I may withdraw this consent at any time and
discontinue further participation in this study without prejudice to my entitlements to care. I also
understand that the investigator of this study may terminate my participation in this study if he or she
feels this to be in my best interest.
Subject/Guardian Signature
Date
Signature of Witness
Date_
Printed Name. Grade or Rank
DATA COLLECTION
ID NUMBER
AMOUNT OF FLUID
SOURCE OF FLUID
AGE SEX
RACE COUNTRY OF BIRTH
# OF INDIVIDUALS IN HOME FROM BIRTH TO 10 YRS
HOUSEHOLD INCOME < 50,000 50,000-100,000 >100,000
EDUCATIONAL LEVEL
DIAGNOSIS
PERTINENT MED. FIX
MEDICATIONS
GROWTH AFTER 7 DAYS
GROWTH AFTER 10 DAYS
CATALASE Pos/Neg OXIDASE Pos/Neg UREASE Pos/Nee
GRAM STAIN
H. PYLORI: NEGATIVE POSITIVE
September, ,1997
Dear Doctor,
My name is Captain Terry McManus and I am a Nurse Practitioner Graduate Student atthe Uniformed Services University of the Health Sciences, (USUHS). Over the last few months, Ihave been collecting gastric fluid samples under the 89 'h MDG & USUHS IRBs approved protocolT06129-01, (18 February 1997). This protocol has been performed as part of my Thesis entitled"The Prevalence of Helicobacter pylori in Gastric Fluid in the Surgical Patient".
On 1997, 1 collected a sample of gastric fluid from , who was underyour care for surgery. The cultures were grown at USUHS in the Gastrointestinal and LiverStudies Laboratory under the guidance of Dr. Andre Dubois MD, PhD. The cultures for thispatient were positive for Helicobacter pylori. Although I thought it might be useful for you toknow this result, I am sure you are aware that it is currently recommended to treat H. pyloriinfection only in patients with Peptic Ulcer Disease or Mucosa Associated Lymphoid Tissue(MALT) lymphoma. Patients who have no specific gastroduodenal complaints and are H. pyloripositive should not be treated for this infection.
If you have any questions, I can be reached at 301-599-6554 or via E-mail atTMCMANUS@AOL.COM.
Sincerely,
Captain Terence J. McManus, NC, USAFFamily Nurse Practitioner StudentGraduate School of NursingUniformed Services University of the Health Sciences
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